Parent Involvement in Adolescent Obesity Treatment



Status:Not yet recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 16
Updated:3/27/2019
Start Date:June 1, 2019
End Date:August 31, 2023
Contact:Janet D Delorme, MS
Email:janet.delorme@vcuhealth.org
Phone:(804) 527-4756

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The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+

A randomized control trial to compare the efficacy of two distinct parent treatments on
weight loss maintenance for adolescents with obesity participating in a lifestyle
intervention including nutrition education, exercise and behavioral support.

Funding support from NIH via 1R01HD095910

Investigators will recruit adolescents with overweight or obesity (BMI>85th percentile) and a
parent (BMI > 25 kg/m2). Families will participate in one of two 4-month treatments: 1)
TEENS+ Parents as Coaches (PAC), engaging parents as helpers in their child's weight
management, or 2) TEENS+ Parent Weight Loss (PWL), engaging parents in their own weight
management. All adolescents will participate in TEENS+, which includes behavioral support,
nutrition education, and supervised physical activity.

For adolescents, the intervention will consist of weekly behavioral weight management group
sessions and weekly 1 hour exercise sessions at the study gym. Each adolescent also has a
monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour
according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent.
Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will
consist of anthropometric measures, psychological surveys and dietary and PA evaluations.
Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1
year.

Inclusion Criteria:

Adolescent Inclusion Criteria:

- BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts

- Age 12 to 16

- Must reside with the primary participating parent

Parent Inclusion Criteria:

- 18 - 60 years of age

- BMI ≥ 25 kg/m2

- Must reside with the adolescent

Exclusion Criteria:

Adolescent Exclusion Criteria:

- Non-English speaking

- Medical condition(s) that may be associated with unintentional weight change

- Diabetes mellitus

- Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an
investigational medication within 3 months of study participation

- Medical condition(s) that may be negatively impacted by exercise

- Psychiatric, cognitive, physical or developmental conditions that would impair the
ability to complete assessments, participate in a group, or conduct physical activity

- Reports of compensatory behaviors in the past 3 months

- Current pregnancy or plan to become pregnant during study period

- Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304

- Current participation in another weight loss program

- Personal history of weight loss surgery

- Clinically significant depression

- Clinically significant eating disorder

- Change in dose of metformin, oral contraceptives, tricyclic antidepressants, selective
serotonin uptake inhibitors, or stimulant medications within 3 months of study
participation

- Admission to a psychiatric hospital within the past year

Parent Exclusion Criteria:

- Non-English speaking

- Medical condition(s) that may be associated with unintentional weight change

- Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an
investigational medication within 3 months of study participation

- Psychiatric, cognitive, physical or developmental conditions that would impair the
ability to complete assessments, participate in a group, or conduct physical activity

- Reports of compensatory behaviors in the past 3 months

- Current pregnancy, lactation, less than 6 months post-partum, or plan to become
pregnant during study period

- Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304

- Current participation in another weight loss program

- Personal history of weight loss surgery

- Clinically significant depression

- Clinically significant eating disorder

- Change in dose of diabetes medications, oral contraceptives, tricyclic
antidepressants, selective serotonin uptake inhibitors, or stimulant medications
within 3 months of study participation

- Admission to a psychiatric hospital within the past year
We found this trial at
1
site
Henrico, Virginia 23239
Phone: 804-527-4756
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from
Henrico, VA
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